510(k) K232426
- Device
- Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
- Applicant
- Conformis, Inc.
- 510(k) number
- K232426
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-08
- Date received
- 2023-08-11
- Regulation
- 888.3565
- Classification name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Mary Kruitwagen
- Address
- 600 Technology Park Dr. Fourth Floor Billerica MA US 01821 01821
FDA Registration Numbers#
- 9616680
- 1646498
- 8010379
- 2528981
- 3022142628
- 9610612
- 3014763043
- 2244478
- 1835444
- 1423662
- 3021008900
- 3004986960
- 3002807314
- 1226188
- 3016851379
- 3010287737
- 3005279746
- 3013417938
- 3033509898
- 3008110533
- 3009813841
- 3009760038
- 3007189546
- 3005562917
- 2648920
- 3005874553
- 1047843
- 1530390
- 3002907620
- 3026771806
- 3009973505
- 3010331645
- 1043653
- 3011061242
- 3004371426
- 2249697
- 3019006180
- 3008868758
- 1644408
- 3006395932
- 2245304
- 3017410889
- 1018470
- 3008262872
- 1064858
- 3007516837
- 9616671
- 8043792
- 1057425
- 1818910
- 3000264985
- 3014833750
- 3009475821
- 9680215
- 1220477
- 3005061536
- 3010220595
- 3009888740
- 3015231789
- 3005144609
- 3010041693
- 3003998208
- 3008021110
- 3010047402
- 3005180920
- 3010375065
- 1020279
- 3004153240
- 3003541440
- 3011015572
- 1061927
- 3003639920
- 1825034
- 2032093
- 2183946
- 3002806470
- 1226544
- 3007539489
- 3042172882
Source Documents#
Other 510(k) Records For Product Code MBH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. | 2026-03-09 |
| K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | 2026-02-26 |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-02-18 |
| K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2025-12-23 |
| K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | 2025-12-19 |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | 2025-10-31 |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-10-24 |
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | United Orthopedic Corporation | 2025-07-31 |
| K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | 2025-05-22 |
| K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. | 2025-03-27 |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-02-13 |
| K243293 | Zimmer® Persona® Personalized Knee System | Zimmer Biomet | 2024-12-20 |
| K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | 2024-12-18 |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | Zimmer, Inc. | 2024-11-22 |
| K242412 | Agility Symmetric™ Total Knee System | Medisurge, LLC | 2024-11-06 |